Degeneration; Bone Clinical Trial
Official title:
Straumann® MembraGel Comparison of a PEG Membrane and a Collagen Membrane for the Treatment of Bone Dehiscence Defects at Bone Level Implants
| Verified date | May 2017 |
| Source | Institut Straumann AG |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The aim of the study is to test in a randomized comparative study the performance of
Straumann® MembraGel (PEG Membrane) to act as a barrier for guided bone regeneration compared
to that of a standard collagen membrane (BioGide®) in the bone regeneration around Straumann®
SLActive bone level titanium implants.
Furthermore the clinical evaluation and comparison of complementary parameters describing the
bony and soft tissue environments at the surgical sites during the study period to evaluate
effectiveness and performance of the membranes.
| Status | Completed |
| Enrollment | 117 |
| Est. completion date | December 2015 |
| Est. primary completion date | October 2011 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - Subjects must have voluntarily signed the informed consent form before any study related action - Males and females must be at least 18 years of age and not more than 80 year old. - Have at least one missing tooth in the posterior mandible or maxilla in quadrant 1, 2, 3, 4 (FDI positions 4-7), requiring one or more dental implants. - Partially edentulous patients and patients in need of a fixed dental prosthesis - The tooth at the implant site(s) must have been extracted or lost at least 6 weeks before the date of implantation. - Bone defect(s) must be present with a vertical dimension greater than or equal to 3 mm at the foreseen GBR site measured after dental implant placement. - Full mouth bleeding on Probing (FMBoP) and full mouth plaque score (FMPI) are both lower or equal than 25% - Patients must be committed to the study. Exclusion Criteria: - Presence of conditions requiring chronic routine prophylactic use of antibiotics (e.g., history of rheumatic heart disease, bacterial endocarditis, cardiac valvular anomalies, prosthetic joint replacements) - Major systemic diseases - Medical conditions requiring prolonged use of steroids - Use of Bisphosphonate intravenously - Current pregnancy or breastfeeding women - Physical or mental handicaps that would interfere with the ability to perform adequate oral hygiene - Alcoholism or chronically drug abuse - Immunocompromised patients - Patients who smoke more than 10 cigarettes per day or cigar equivalents, or who chew tobacco - Conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, or unreliability. Local exclusion criteria - Local inflammation, including untreated periodontitis - Regenerative treatment necessary adjacent to the planned study site of interest - Mucosal diseases or oral lesions - History of local irradiation therapy - Severe bruxing or clenching habits - Persistent intraoral infection - Patients with inadequate oral hygiene or unmotivated for adequate home care - Previous GBR or GTR treatment at the implant site - Lack of primary stability of the dental implant at site of interest. In this instance the patient must be withdrawn and the patient treated accordingly (exclusion criteria at surgery) |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Catholic University Leuven School of Dentistry, Oral Pathology & Maxillo-facial Surgery | Leuven | |
| Germany | Charite | Berlin | |
| Germany | Universitätsklinikum Düsseldorf | Düsseldorf | |
| Hungary | Semmelweis University | Budapest | |
| Italy | Eastman Hospital | Rome | |
| Spain | Prof. Mariano Sanz | Madrid | |
| Spain | Clinica Blanco Ramos | Santiago de Compostela | |
| Sweden | Gävle Hospital | Gävle | |
| Switzerland | Medical University Zürich | Zürich |
| Lead Sponsor | Collaborator |
|---|---|
| Institut Straumann AG |
Belgium, Germany, Hungary, Italy, Spain, Sweden, Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The Bone Fill Was Assessed at 6 Months After Regenerative Therapy. | Change between baseline (regenerative therapy) and the 6 months timepoint is reported. | Assessed at 6 months reported |